Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
06/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZEN1033IL/27

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised Double-Blind Double Dummy Trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Breast cancer

Intervention

1. Group A: Arimidex (anastrozole) 1 mg plus tamoxifen placebo daily
2. Group B: Tamoxifen 20 mg plus Arimidex placebo daily

Intervention type

Drug

Phase

Not Specified

Drug names

Arimidex with Tamoxifen

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1996

Overall trial end date

01/07/1998

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with locally advanced or metastatic breast cancer who are candidates to receive hormonal therapy as first line therapy for advanced disease (patients may have received adjuvant chemotherapy or hormonal therapy but patients who have received tamoxifen as adjuvant therapy must have an interval of at least 12 months since stopping tamoxifen and entry into this trial)
2. Post-menopausal defined as:
2.1 Aged >50 years or who have not menstruated during the preceding 12 months or who have follicle-stimulating hormone (FSH) levels within the post-menopausal range
2.2 Women aged <50 years who have FSH levels within the post-menopausal range
3. Hormone receptor (oestrogen receptor and or progesterone receptor) positive or unknown
4. Measurable or evaluable disease
5. No previous systemic therapy for advanced breast cancer
6. No drug-maintained menopausal status
7. No evidence of life threatening visceral disease
8. Life expectancy of >3 months
9. No treatment with a non-approved or experimental drug within the preceding 3 months before randomisation
10. No prior history of other malignancy other than breast cancer, except basal cell or squamous cell carcinoma of the skin or cancer of the cervix which has been satisfactorily controlled
11. No contraindications to protocol treatments

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1996

Recruitment end date

01/07/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

AstraZeneca Clinical Research Group (UK)

Sponsor details

10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
EH7 4HG
United Kingdom

Sponsor type

Industry

Website

http://www.astrazeneca.co.uk

Funders

Funder type

Industry

Funder name

AstraZeneca Pharmaceuticals (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes